Breckenridge initiates Paragraph IV ANDA litigation with Boehringer over Pradaxa generic

13 March 2015

Privately-held Breckenridge Pharmaceutical has filed an Abbreviated New Drug Application with a Paragraph IV certification for dabigatran etexilate mesylate capsules, a generic of Pradaxa from German family-owned pharma major Boehringer Ingelheim.

Boehringer filed a Paragraph IV law suit against Breckenridge in the USA on March 5 with the District Court for New Jersey, while Breckenridge filed its Paragraph IV ANDA on the first possible submission date, and expects to be granted 180-day exclusivity.

Pradaxa, indicated to reduce stroke and systemic embolism risk, generated sales of $880 million for the year ending January 2015.

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